On April 27, 2022, the Workplace of Inspector Normal (OIG) revealed Advisory Opinion 22-08 (Advisory Opinion) by which it declined to impose sanctions towards a federally certified well being heart (Requestor) for an association involving the loaning of smartphones to sufferers to permit these sufferers to obtain telehealth providers from the Requestor. The OIG concluded that though the association would represent prohibited remuneration below the Federal anti-kickback statute (AKS) and the beneficiary inducement prohibitions of the Civil Financial Penalties Regulation (CMP), the restricted scope of the association and the safeguards in place didn’t warrant the imposition of sanctions.
As a federally certified well being heart, the Requestor primarily serves low-income people, together with beneficiaries of federal well being care applications. Beneath the association, the Requestor loaned smartphones to roughly 3,000 of its present sufferers. The smartphones have been supplied on a first-come, first-serve foundation for functions of permitting the sufferers to obtain telehealth providers and to scale back social isolation, together with in the course of the COVID-19 pandemic. Solely sufferers who obtained a service from the Requestor within the prior 24 months and who didn’t have a telehealth-compatible smartphone have been eligible to obtain a smartphone from the Requestor. Sufferers might retain the smartphone if the Requestor has supplied no less than one service to the affected person inside the prior 24 months; if no such service was supplied, the affected person is required to return the smartphone. The smartphones are locked and have restricted functionality—customers are solely ready to make and obtain cellphone calls and textual content messages, entry the telehealth utility utilized by the Requestor, and think about the relevant affected person’s medical information. Sufferers might use the smartphone to obtain telehealth providers from different suppliers, however they need to solely use the telehealth utility utilized by the Requestor that’s loaded onto the smartphone. In accordance to the Requestor, the telehealth providers it offers by way of the smartphone telehealth utility are presently reimbursable by Medicare and Medicaid. Prior to issuance of the Advisory Opinion, the Requestor ended its mortgage program and won’t mortgage extra smartphones or present different sufferers with smartphones.
The Federal Communications Fee and a neighborhood charity supplied Requestor with the funding to buy the smartphones; nevertheless, the Requestor did present sufferers with two months of voice and knowledge service for the smartphones. Requestor licensed that it’ll not fund extra voice and knowledge providers, and that the sufferers should pay for such providers to proceed utilizing the smartphones.
In accordance to the OIG, the association implicates each the AKS and the beneficiary inducement prohibition of the CMP as a result of permitting the sufferers to proceed use of the smartphones for free may induce these sufferers to obtain Medicare-reimbursable objects and providers from the Requestor.
The OIG first analyzed the beneficiary inducements prohibition and concluded that in the course of the COVID-19 public well being emergency (PHE) the association happy the “promotes access to care” exception within the CMP as follows:
The association reduces socioeconomic limitations to care and improves beneficiaries’ entry to care as a result of the Requestor serves a major proportion (94%) of sufferers which are at or under 200% of the federal poverty tips, and sufferers are eligible for the association provided that they don’t possess a smartphone succesful of receiving telehealth;
Nothing within the association suggests it should have an effect on medical decision-making;
Though the association might improve utilization of telehealth providers, nothing in its construction means that such improve could be inappropriate as a result of the association is proscribed to the present sufferers which have a loaned smartphone, and every affected person is required to obtain just one service from the Requestor over a 24-month interval to retain the smartphone. The OIG discovered that this lowered the chance of sufferers searching for care from the Requestor solely to retain the smartphone; and
There was no proof that the Requestor would supply telehealth providers if doing so would increase affected person security or high quality of care issues and, in the course of the PHE, offering a telehealth choice to sufferers is probably going to promote affected person security.
The OIG restricted the above evaluation to the PHE as a result of the OIG is unsure whether or not the telehealth providers supplied by the Requestor will proceed to be coated by Medicare or Medicaid following the top of the PHE. Nonetheless, the OIG additional concluded that even when the association doesn’t meet the “promotes access to care” CMP exception, it could not impose sanctions due to the low-risk nature of the association.
The OIG subsequent turned to the AKS. It concluded that though no secure harbor utilized to the association, it presents not more than a minimal threat of fraud and abuse for the identical causes as analyzed below the CMP. The OIG additional famous that the fraud and abuse threat was low as a result of the smartphones have been bought with funding from entities that haven’t any monetary curiosity in sufferers receiving care from the Requestor.
Though the association addressed on this Advisory Opinion is of restricted scope and length, the OIG’s evaluation offers perception to well being care suppliers on safeguards to think about incorporating into modern applications meant to promote entry to care, notably via use of telehealth—each throughout and after the PHE.
Because the OIG has emphasised, its Advisory Opinions are issued solely to the requestors of the opinion, and haven’t any utility to, and can’t be relied upon by, any particular person or entity, nor might they be launched into proof by anybody aside from the requestors to show the person or entity didn’t violate the anti-kickback statute or some other legislation.